Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT01950572

Collaborator

(none)

1,000

Enrollment

Location

250

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.

Objectives:

-To allow sample acquisition for use in the study of mesothelioma.

Eligibility:

All patients age greater than or equal to 2 years with malignant mesothelioma
Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18

Design:

Up to 1000 subjects will be enrolled.
Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.
Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

Condition or Disease	Intervention/Treatment	Phase
Mesothelioma Thymoma Pancreatic Neoplasms Biliary Tract Neoplasms Stomach Neoplasms

Detailed Description

Background:

Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.
In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.
Mesothelin expression level has been correlated with improved overall survival in thymic cancer and with reduced overall survival in patients with lung cancer.

Objective:

-To allow sample acquisition for use in the study of mesothelioma and other mesothelin expressing cancers.

Eligibility:

All patients age greater than or equal to 2 years with malignant mesothelioma
All patients age greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers
Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18

Design:

Up to 1000 subjects will be enrolled.
Patients will be followed to determine the course of disease and to record any treatment received for the eligible mesothelin expressing cancer.
Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers

Actual Study Start Date :

Sep 9, 2013

Anticipated Primary Completion Date :

Jul 25, 2033

Anticipated Study Completion Date :

Jul 11, 2034

Arms and Interventions

Arm	Intervention/Treatment
1/Eligible cancer diagnosis Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers

Outcome Measures

Primary Outcome Measures

sample aquisition [Ongoing]
allow sample acquisition for use in the study of mesothelioma

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
All patients greater than or equal to 2 years of age with malignant mesothelioma.
All patients greater than or equal to18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers.
Confirmed pathological diagnosis is required
Ability and willingness of subject to provide informed consent to participation.

EXCLUSION CRITERIA:

Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
Pregnant or breast feeding women will be eligible for this protocol, but will not undergo tumor biopsy.
Active concomitant medical or psychological illnesses that may increase the risk to the subject or in adult patients, inability to obtain informed consent, at the discretion of the principal investigator.